Postoperative Patient Controlled Epidural Analgesia After Total Knee Arthroplasty With 2ug/ml Fentanyl Combine With 0.2% Ropivacaine or 0.2% Levobupivcaine

Sponsor

United Christian Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01158586

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Postoperative epidural analgesia (EA) is an effective and well-accepted modality of pain relief technique after having total knee replacement operation(1,4). Patient controlled epidural analgesia (PCEA) has been shown to be safe and effective in standard ward setting(2) and results in reduced epidural analgesic requirements(3). Besides, it also bear the advantage of avoidance of overdose, reduction of waiting times and involvement of patients in their analgesic regimen(3). Both ropivacaine and levobupivacaine are the local anaesthetic using in epidural analgesia which has been proven to be safe and effective(4). 0.2% Ropivacaine with 2ug/ml fentanyl has been used in our locality for more than 8 years. Another local anaesthetics, levobupivacaine, a S-enantiomer of bupivacaine has come up in Hong Kong, which has been proved to be safe, effective and may be better value for money. These two drugs has been proven to have similar analgesic potency in using as EA for postoperative pain relief for other operation(5,6,7) and for orthropaedics operation but in different concentration(4). Concerns have been raised about the introduction of the levobupivacaine in the departmental protocol. Objectives of this study are A)to determine the equivalence of two local anaesthetics regimen ; 0.2% ropivacaine with 2ug/ml fentanyl and 0.2% levobupivacaine with 2ug/ml fentanyl and B) to assess the cost-effectiveness of using these two regimens.

The null hypothesis is that the difference of analgesic effect, presented with visual analogue score, of two patient controlled epidural analgesia regimen, the 0.2% ropivacaine with 2 ug/ml fentanyl and 0.2% levobupivacaine with 2ug/ml fentanyl is higher than the threshold of 9 mm VAS. (8,9,10)

Condition or Disease	Intervention/Treatment	Phase
Arthroplasty, Replacement, Knee Patient-controlled Analgesia	Drug: Levobupivacaine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Apr 1, 2010

Anticipated Primary Completion Date :

Sep 1, 2010

Anticipated Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Levobupivacaine patient control epidural analgeisa using 0.2% levobupivacaine with 2ug/ml fentanyl	Drug: Levobupivacaine patient control epidural analgesia using 0.2% levobupivacaine with 2ug/ml fentanyl
Active Comparator: Ropivacaine patient controlled epidural analgesia using 0.2% ropivacaine with 2ug/ml fentanyl	Drug: Levobupivacaine patient control epidural analgesia using 0.2% levobupivacaine with 2ug/ml fentanyl

Arm

Intervention/Treatment

Experimental: Levobupivacaine

patient control epidural analgeisa using 0.2% levobupivacaine with 2ug/ml fentanyl

Drug: Levobupivacaine

patient control epidural analgesia using 0.2% levobupivacaine with 2ug/ml fentanyl

Active Comparator: Ropivacaine

patient controlled epidural analgesia using 0.2% ropivacaine with 2ug/ml fentanyl

Drug: Levobupivacaine

patient control epidural analgesia using 0.2% levobupivacaine with 2ug/ml fentanyl

Outcome Measures

Primary Outcome Measures

Pain score [48hours after start epidural analgesia]
as well as complications from epidural analgesia are also going to record and monitored

Secondary Outcome Measures

cost/treatment [48hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years old, ASA I -III and
Undergoing total knee arthroplasty
Combine spinal-epidural anaesthesia

Exclusion Criteria:

Known hypersensitivity to amide-type local anaesthetics
Known hypersensitivity to opioids
Known history of severe cardiovascular, renal, hepatic, neurological or psychiatric disease as judged by the investigator
Known history of peripheral neuropathies
Those receiving chronic analgesic therapy, or any contraindication for epidural analgesia (e.g. clotting disorders, or history of lumbar surgery)
Inability to perform a pain score, or pregnancy or lactation